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FDA Clears Hayek RTX Ventilator for Use After First Patient in US Experienced Immediate, Dramatic Improvement at WCHOB

Updated: 10/23/2008

Dr. Joe Cronin with others from the Lung & Cystic Fibrosis Center announce the FDA has cleared for use the Hayek RTX Ventilator within weeks after Cystic Fibrosis patient Tyler Blake, 26, of Celoron, NY, became the first and only patient in the United States to receive treatment from this device at WCHOB

The U.S. Food & Drug Administration (FDA) recently cleared for use the Hayek RTX Ventilator within weeks after Cystic Fibrosis patient Tyler Blake, 26, of Celoron, NY, recently became the first and only patient in the United States to receive treatment from this device at Women & Children's Hospital of Buffalo.

Before Tyler received treatment from an Hayek RTX Ventilator, his lung function continued to deteriorate despite maximum interventions, including multiple chest tube procedures, constant reliance on a BiPap ventilator and an invasive surgery to remove a damaged portion of his lung.

Within 24 hours of this treatment, Tyler’s lung function improved dramatically. He was successfully weaned from the BiPap device, which immediately allowed him to eat solid foods and sleep more comfortably for longer periods. Within two weeks, previously necessary medications were discontinued and his chest tube was removed.

This immediate and dramatic improvement in Tyler’s condition is a direct result of treatment with the Hayek RTX Ventilator, which was approved by the FDA for compassionate care in this first and only use in the United States, according to Joseph Cronin, M.D., Director Adult CF Program, Women & Children’s Hospital of Buffalo, and Assistant Clinical Professor Internal Medicine and Pediatrics, University at Buffalo School of Medicine & Biomedical Sciences, who is directing Tyler’s care.

“The effect that the Hayek RTX has had on Tyler’s recovery is extraordinarily impressive and unquestionable,” said Dr. Cronin.

Use of the Hayek RTX Ventilator became possible when Dr. Cronin, in a plea for compassionate use first to its manufacturer and the hospital’s Internal Review Board and then directly to the FDA, received prompt approvals from each to proceed with his care plan incorporating the devise.

The RTX Ventilator, currently in use throughout Europe and Asia, functions differently than conventional ventilators presently available in the US. This technology is non-invasive and utilizes a cushioned external chest cuirass device (“chest shell”), enabling patients to breathe more naturally by sensing and responding to an individual’s efforts and enhancing them. Unlike the old “iron lung,” the RTX is a “Biphasic” ventilator that helps in both the inspiratory and expiratory phases of respiration.

The RTX applies a negative pressure field across the patient’s chest to help with chest expansion when the patient breathes in. When the patient breathes out, the RTX is also helpful by applying additional positive pressure around the chest wall. This is helpful to a patient for whom breathing out is just as hard as breathing in. The principle behind the Hayek biphasic cuirass method is to help the patient breathe in the way they naturally would.

The RTX also has multiple other features that assist in mucous clearance as well as augmenting a patient’s effort to cough. The ability to cough and clear mucous from airways is often impaired by standard positive pressure ventilators that try to push air into lungs, a process which is contrary to our normal breathing mechanism.

The Hayek RTX is applicable for people of all ages and for numerous other medical conditions, including COPD, Pneumonia, neuromuscular diseases such as Duchennes’ Muscular Dystrophy and Spinal Muscular Atrophy, chronic and acute respiratory failure and weaning from invasive ventilation.

“We are delighted with the improvement and progress in Tyler’s health. It has always been and continues to be our mission, using our Hayek method of ventilation, to improve quality of life and treatment for patients and to offer viable non-invasive respiratory solutions where in many cases there are none. We are looking forward to being able to make available the Hayek RTX to patients throughout the United States.” Shahar Hayek, Medivent International

The Hayek RTX Ventilator and the method of Biphasic Cuirass Ventilation (BCV) was invented and developed by Dr. Zamir Hayek. Medivent International is based in London, England.

The Cystic Fibrosis Center of Western New York at Women & Children’s Hospital is certified by the national Cystic Fibrosis Center as a Care, Teaching and Research Center. It includes both Pediatric and Adult Programs, with care provided to adults by internal medicine certified specialists. Its work has been instrumental in bringing several new medical therapies for CF from the research arena to use in daily care. The Center is the recipient of a National Cystic Fibrosis Foundation Clinical Research Facilitation Award.

Women & Children’s Hospital of Buffalo, a Kaleida Health facility and teaching hospital for the University at Buffalo School of Medicine & Biomedical Sciences, is the regional center for specialized pediatric, perinatal and obstetrical services in Western New York and beyond.